Changing the Surgical Team for Wound Closure and Surgical Site Infection

NCT04503642 | Completed DMC

• 1 other identifier: CLOT-T trial
• Study Type: observational
• Target: 1,160
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infection is a frequent complication after abdominal surgery. The wound closure is done at the end of the procedure when the attention of the entire team may be affected because of tiredness and reduced attention of the surgical team. With this study, the investigators aim to test if an exchange of the surgical team by a specialised wound closure team may reduce the impact of surgical site infection.

Conditions

Incidence of Surgical Site Infection; Morality; Fascial Hernia

Keywords

Surgical Site Infection; Changing the surgical team

Outcome Measures

Primary Outcomes (1)

• Number of patients with SSIs

  SSI that occur after surgery will be assessed according to the criteria developed by the Centers for Disease Control and Prevention. Infections will be categorized as incisional (superficial or deep) infections or organ-space infections. Superficial SSI (type 1) involve only skin and subcutaneous tissue and exclude stitch abscesses. Deep SSI (type 2) involve deeper soft tissues, like fascia and muscle, at the site of incision. Organ-space SSI (type 3) involve any organ or body cavity

  30 days postoperative

Secondary Outcomes (3)

• Postoperative Mortality at 30 days

  30 days postoperative

• Numbers of patients with fascial dehiscence at 30 days postoperative

  30 days postoperative

• Numbers of patients with complications

  30 days postoperative

Study Arms (2)

Intervention Group

The intervention consisted in the closure of the abdominal wall and skin by a second surgical team which included a board-certified surgeon and a resident.

Procedure: Changing the surgical team for wound closure

Baseline Group

During the baseline period, closure of the abdominal wall was performed by the main surgical team, the same team that performed the whole surgery.

Interventions

Changing the surgical team for wound closure PROCEDURE

The intervention consists of the exchange of the primary surgical team with a second surgical team that consists of one surgeon and one student. The first surgical team then may leave the operation theatre but is continuously accessible for questions.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Department of Visceral Surgery of the University Hospital Bern, a tertiary care centre

You may qualify if:

• General Consent as documented by signature
• Patients undergoing elective or emergency abdominal surgery from Monday to Friday with wound closure from 8:00 until 17:30 and duration of operation.
• Age over 18 years

You may not qualify if:

• Patients \< 18 years of age
• Patients with preexisting SSI

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Salm L, Chapalley D, Perrodin SF, Tschan F, Candinas D, Beldi G. Impact of changing the surgical team for wound closure on surgical site infection: A matched case-control study. PLoS One. 2020 Nov 5;15(11):e0241712. doi: 10.1371/journal.pone.0241712. eCollection 2020.

  PMID: 33151978 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guido Beldi, MD

  Visceral and transplant sugery, university hospital Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 7, 2020
• Study Start: March 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: February 28, 2019
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

CH (1)